StrokeNCT03651479
The Comparison of Virtual and Real Boxing Training in Hemiparetic Stroke Patients
A study testing real boxing training and virtual boxing training in people with Stroke and Hemiparesis, run by Eastern Mediterranean University at 1 site in Cyprus.
Trial summary
The aim of this study is to compare the effects of virtual and real boxing training in addition to neurodevelopmental training on cognitive status, upper extremity functions, balance and activities of daily living in hemiparetic stroke patients. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Stroke, Hemiparesis
- What is being tested?
- real boxing training and virtual boxing training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteCyprus
- Study dates
- 10 Nov 2018to 12 Jun 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients diagnosed with first time ever stroke
- Patients with hemiparesis
- Patients who are between the ages of 18-70
- Patients who has Mini Mental Test score above 23
- Patients whose functional level is less than 4 according to the Modified Rankin Scale
- Patients who has upper extremity spasticity lower than 3 on Modified Ashworth Scale
Who cannot join
- Hypertension
- Heart disease
- Subluxation and fracture at the shoulder
- Visual impairment
- Limitation in passive normal joint movement in hemiplegic side
- Botulinum toxin administration or surgical operation in the last 6 months patients
Trial locations and contacts
1 site in 1 country.
Cyprus1 site
Eastern Mediterranean University
Famagusta, North Cyprus Via Mersin 10 Turkey, 99450
About this study
Official title: The Comparison of Virtual and Real Boxing Training in Hemiparetic Stroke Patients: a Randomized Controlled Study
The aim of this study is to compare the effects of virtual and real boxing training in addition to neurodevelopmental training on cognitive status, upper extremity functions, balance and activities of daily living in hemiparetic stroke patients.
Read the detailed description
The use of computer systems has become a highly accepted approach in neurorehabilitation currently. Virtual reality (VR) is frequently used in different disease groups for this purpose. By using various VR equipment (sensors, balance board, control, etc.), exercises can be individualized to suit individual needs and aim to stimulate neural plasticity according to motor learning principles with repetitive activities.
In recent years, it has been observed that boxing training (boxing therapy) in individuals with neurological diseases (e.g. Parkinson's disease and stroke) gives positive results. It has been shown in the literature there are short and long-term improvement in daily life activities, quality of life, balance and gait functions after boxing training in patients with Parkinson' disease despite the progressive nature of Parkinson's disease. Additionally it was found that boxing program in sitting has positive effects on upper extremity functions, balance, walking and quality of life in stroke patients. In the literature, there were no studies comparing virtual and boxing therapy in stroke patients. Therefore, the aim of this study is to compare the effects of virtual and real boxing training in addition to neurodevelopmental training (NDT) on cognitive status, upper extremity functions, balance and activities of daily living in hemiparetic stroke patients.
Patients who have had a stroke for the first time with hemiparesis, who are between the ages of 18-70, who has Mini Mental Test score above 23, whose functional level is less than 4 according to the Modified Rankin Scale, who has upper extremity spasticity lower than 3 on Modified Ashworth Scale will be included in this study. In case of hypertension which may prevent rehabilitation, heart disease, subluxation and fracture at the shoulder, visual impairment, limitation in passive normal joint movement in hemiplegic side, botulinum toxin administration or surgical operation in the last 6 months patients will not be excluded.
All the patients will be measured with Addenbrooke's Cognitive Assessment (ACA), Minnesota Hand Skill Test, Wolf Motor Function Test (WMFT), Fullerton Advanced Balance Scale (FAB), Frenchay Activity Index (FAI) and video boxing analysis of punching.The measurements will be made at the beginning of the treatment (0 weeks) and at the end of the treatment (8 weeks).
NDT approaches consist of upper extremity facilitation techniques and activities in accordance with the patient's functional level, weight transfer and walking exercises to increase sitting and standing balance, mat exercises with the same purpose considering the functional level for each patient. In the real boxing (RB) group in addition to the NDT program, real boxing training will be given. Accordingly, the physiotherapist and the patient will wear boxing gloves and the patients will punch the physiotherapist's glove with a pre-specified treatment protocol. Resistance and frequencies between levels will be increased by the physiotherapist as the sessions progress. The RB group will have 30 minutes of real boxing training for 3 sessions per week for 8 weeks. In the virtual boxing (VB) group, in addition to the NDT program, virtual boxing training will be given by using Kinect Xbox Boxing. For the VB group, virtual boxing training will be held for 3 weeks 30 minutes a week for 8 weeks.
- Conditions
- Stroke, Hemiparesis
- Being tested
- real boxing training, virtual boxing training
- Keywords
- virtual reality, boxing, upper extremity function, cognitive function, balance
- Medical subject headings
- Stroke, Paresis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
real boxing trainingOther
In the real boxing (RB) group in addition to the NDT program, real boxing training will be given. Accordingly, the physiotherapist and the patient will wear boxing gloves and the patients will punch the physiotherapist's glove with a pre-specified treatment protocol. Resistance and frequencies between levels will be increased by the physiotherapist as the sessions progress. The RB group will have 30 minutes of real boxing training for 3 sessions per week for 8 weeks.
virtual boxing trainingOther
In the virtual boxing (VB) group, in addition to the NDT program, virtual boxing training will be given by using Kinect Xbox Boxing. For the VB group, virtual boxing training will be held for 3 weeks 30 minutes a week for 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| real boxing group | Experimental | In the real boxing (RB) group in addition to the NDT program, real boxing training will be given. Receives: Other: real boxing training |
| virtual boxing group | Experimental | In the virtual boxing (VB) group, in addition to the NDT program, virtual boxing training will be given by using Kinect Xbox Boxing. Receives: Other: virtual boxing training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wolf Motor Function Test
Wolf Motor Function Test (WFMT) quantifies upper extremity motor ability through the use of timed and functional tasks. The widely used version of the WMFT consists of 17 items, items 7 and 14 are related to subject strength and the other 15 to subject functional ability during various tasks. Performances are scored using a 6-point functional ability scale and the less affected upper extremity followed by the most affected side. The total score, also referred to as Functional Ability score (WMFT-FAS), is the sum of the 15 items score (with a 6-point ordinal score from 0 to 5). The maximum total score is 75 and minimum is 0. Lower scores indicating lower functional levels.
Measured: 8 weeks
Secondary outcomes (5)
Minnesota Manual Dexterity Test
Minnesota Manual Dexterity Test (MMDT) measures the speed of gross arm and hand movements (arm-hand dexterity) during rapid eye-hand coordination tasks. The MMDT involve five subtests:The Placing Test (1st item: taking the blocks with one hand and putting them in the holes on the board in a standardized order) and Two-hand Turning and Placing Test (5th item: taking the blocks with two hands and putting them in the holes on the board in a standardized order) were the two items selected for this study.The number of seconds it took to complete the task on each of the trials was recorded. The lower the score, the better the outcome.
Measured: 8 weeks
Video Boxing Analysis of Punching
Video Boxing Analysis (VBA) evaluation method was used to evaluate the goal-oriented performance analysis of upper extremity. For boxing analysis patients were videotaped while punching with their right side, punching with side left and punching bilaterally. Than the videotape were watched to analyze and the number of right unilateral punches in 1 minute, number of left unilateral punches in 1 minute and number of bilateral punches in 1 minute were recorded. This analysis were done for the quantitative assessment of punch number per minute (number of punch/minute). This measurement method is created and constructed by the authors of this study. Higher number of punches indicate better outcome on this analysis.
Measured: 8 weeks
Fullerton Advanced Balance Scale
Fullerton Advanced Balance (FAB) scale was developed to evaluate sensitive changes in many aspects of balance. This performance-based scale consists of 10 test items assessing functional balance (static and dynamic) status in older people. The individual test items are: 1. Feet together, eyes closed, 2. Reach forward to retrieve an object, 3. Turn in a full circle, 4. Step up and over a bench, 5. Tandem walk, 6. Stand on one leg, 7. Stand on foam, eyes closed, 8. Two-footed jump, 9. Walk with head turns, 10. Reactive postural control. Each test item is scored using a 0-4 scale. The highest score that can be obtained on this multidimensional balance assessment is 40 points, and the lowest is zero. Higher scores indicate better balance abilities. The FAB scale is quick to administer (~10-12 minutes) and can be administered in a relatively small area.
Measured: 8 weeks
Addenbrooke's Cognitive Assessment
Addenbrook's Cognitive Assessment - Revised (ACE-R) is sensitive in the differential diagnosis of early stage dementia. However, the design and psychometric properties is also suitable to provide information about cognitive functions and cognitive deficits in patients without dementia after a stroke. The ACE-R consists of five domains including attention/orientation, memory, verbal fluency, language and visuospatial ability. The ACE-R total scale score ranges from 0 to 100. The ACE-R subscale scores ranges between; 0-18 points for attention, 0-26 for memory, 0-14 for fluency, 0-26 for language and 0-16 for visuospatial processing. Higher scores indicate better cognitive functioning. ACE- R scale was found as reliable and valid in Turkish population.
Measured: 8 weeks
Frenchay Activities Index
Frenchay Activities Index is a measure of instrumental activities of daily living (IADL) for use with patients recovering from stroke. The Frenchay Activities Index (FAI) assesses a broad range of activities associated with everyday life. The benefit of the FAI is that while activities of daily living scales tend to focus on issues related to self-care and mobility. The FAI comprises 15 activities, each of which is scored on a 4-point scale (0 to 3), to yield a total score ranging from 0 (inactive) to 45 (active). Scoring is based on the frequency with which the activities are carried out. It can be broken down into three subscales: domestic chores, leisure/work, and outdoor activities. Each subscale's score ranges from 0 to 15.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2018
- Study start10 Nov 2018
- Primary completion12 Jun 2019
- Study completion12 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled study
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eastern Mediterranean University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gözde İyigün, Eastern Mediterranean University
- Investigators
- Gozde Iyigun, PhD, Principal investigator, Eastern Mediterranean University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03651479
- Sponsor's protocol ID
- 2018/02(a)-08
- Status last verified
- Nov 2021
- First submitted
- 10 Aug 2018
- Last updated
- 30 Nov 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Park J, Gong J, Yim J. Effects of a sitting boxing program on upper limb function, balance, gait, and quality of life in stroke patients. NeuroRehabilitation. 2017;40(1):77-86. doi: 10.3233/NRE-161392.
PubMed 27792020Sin H, Lee G. Additional virtual reality training using Xbox Kinect in stroke survivors with hemiplegia. Am J Phys Med Rehabil. 2013 Oct;92(10):871-80. doi: 10.1097/PHM.0b013e3182a38e40.
PubMed 24051993
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Comparison of Virtual and Real Boxing Training in Hemiparetic Stroke Patients: a Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT03651479
- Acronym / sponsor ID
- 2018/02(a)-08
- Conditions
- Stroke, Hemiparesis
- Keywords
- virtual reality, boxing, upper extremity function, cognitive function, balance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Eastern Mediterranean UniversityUniversity, hospital or other
- Study start
- 10 Nov 2018 (actual)
- Primary completion
- 12 Jun 2019 (actual)
- Study completion
- 12 Jun 2019 (actual)
- First posted
- 29 Aug 2018 (actual)
- Results
- Posted 18 Jan 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to compare the effects of virtual and real boxing training in addition to neurodevelopmental training on cognitive status, upper extremity functions, balance and activities of daily living in hemiparetic stroke patients.
Detailed description
The use of computer systems has become a highly accepted approach in neurorehabilitation currently. Virtual reality (VR) is frequently used in different disease groups for this purpose. By using various VR equipment (sensors, balance board, control, etc.), exercises can be individualized to suit individual needs and aim to stimulate neural plasticity according to motor learning principles with repetitive activities.
In recent years, it has been observed that boxing training (boxing therapy) in individuals with neurological diseases (e.g. Parkinson's disease and stroke) gives positive results. It has been shown in the literature there are short and long-term improvement in daily life activities, quality of life, balance and gait functions after boxing training in patients with Parkinson' disease despite the progressive nature of Parkinson's disease. Additionally it was found that boxing program in sitting has positive effects on upper extremity functions, balance, walking and quality of life in stroke patients. In the literature, there were no studies comparing virtual and boxing therapy in stroke patients. Therefore, the aim of this study is to compare the effects of virtual and real boxing training in addition to neurodevelopmental training (NDT) on cognitive status, upper extremity functions, balance and activities of daily living in hemiparetic stroke patients.
Patients who have had a stroke for the first time with hemiparesis, who are between the ages of 18-70, who has Mini Mental Test score above 23, whose functional level is less than 4 according to the Modified Rankin Scale, who has upper extremity spasticity lower than 3 on Modified Ashworth Scale will be included in this study. In case of hypertension which may prevent rehabilitation, heart disease, subluxation and fracture at the shoulder, visual impairment, limitation in passive normal joint movement in hemiplegic side, botulinum toxin administration or surgical operation in the last 6 months patients will not be excluded.
All the patients will be measured with Addenbrooke's Cognitive Assessment (ACA), Minnesota Hand Skill Test, Wolf Motor Function Test (WMFT), Fullerton Advanced Balance Scale (FAB), Frenchay Activity Index (FAI) and video boxing analysis of punching.The measurements will be made at the beginning of the treatment (0 weeks) and at the end of the treatment (8 weeks).
NDT approaches consist of upper extremity facilitation techniques and activities in accordance with the patient's functional level, weight transfer and walking exercises to increase sitting and standing balance, mat exercises with the same purpose considering the functional level for each patient. In the real boxing (RB) group in addition to the NDT program, real boxing training will be given. Accordingly, the physiotherapist and the patient will wear boxing gloves and the patients will punch the physiotherapist's glove with a pre-specified treatment protocol. Resistance and frequencies between levels will be increased by the physiotherapist as the sessions progress. The RB group will have 30 minutes of real boxing training for 3 sessions per week for 8 weeks. In the virtual boxing (VB) group, in addition to the NDT program, virtual boxing training will be given by using Kinect Xbox Boxing. For the VB group, virtual boxing training will be held for 3 weeks 30 minutes a week for 8 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized controlled study
| Arm | Type | Receives |
|---|---|---|
| real boxing group | Experimental | Other: real boxing trainingIn the real boxing (RB) group in addition to the NDT program, real boxing training will be given. |
| virtual boxing group | Experimental | Other: virtual boxing trainingIn the virtual boxing (VB) group, in addition to the NDT program, virtual boxing training will be given by using Kinect Xbox Boxing. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients diagnosed with first time ever stroke
- Patients with hemiparesis
- Patients who are between the ages of 18-70
- Patients who has Mini Mental Test score above 23
- Patients whose functional level is less than 4 according to the Modified Rankin Scale
Key exclusion criteria (6 listed)
- Hypertension
- Heart disease
- Subluxation and fracture at the shoulder
- Visual impairment
- Limitation in passive normal joint movement in hemiplegic side
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| real boxing trainingIn the real boxing (RB) group in addition to the NDT program, real boxing training will be given. Accordingly, the physiotherapist and the patient will wear boxing gloves and the patients will punch the physiotherapist's glove with a pre-specified treatment protocol. Resistance and frequencies between levels will be increased by the physiotherapist as the sessions progress. The RB group will have 30 minutes of real boxing training for 3 sessions per week for 8 weeks. | Other | real boxing group |
| virtual boxing trainingIn the virtual boxing (VB) group, in addition to the NDT program, virtual boxing training will be given by using Kinect Xbox Boxing. For the VB group, virtual boxing training will be held for 3 weeks 30 minutes a week for 8 weeks. | Other | virtual boxing group |
Primary outcome
Wolf Motor Function Test
Time frame: 8 weeks
Wolf Motor Function Test (WFMT) quantifies upper extremity motor ability through the use of timed and functional tasks. The widely used version of the WMFT consists of 17 items, items 7 and 14 are related to subject strength and the other 15 to subject functional ability during various tasks. Performances are scored using a 6-point functional ability scale and the less affected upper extremity followed by the most affected side. The total score, also referred to as Functional Ability score (WMFT-FAS), is the sum of the 15 items score (with a 6-point ordinal score from 0 to 5). The maximum total score is 75 and minimum is 0. Lower scores indicating lower functional levels.
5 secondary outcomes
Minnesota Manual Dexterity Test
Time frame: 8 weeks
Video Boxing Analysis of Punching
Time frame: 8 weeks
Fullerton Advanced Balance Scale
Time frame: 8 weeks
Addenbrooke's Cognitive Assessment
Time frame: 8 weeks
Frenchay Activities Index
Time frame: 8 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 27792020Park J, Gong J, Yim J. Effects of a sitting boxing program on upper limb function, balance, gait, and quality of life in stroke patients. NeuroRehabilitation. 2017;40(1):77-86. doi: 10.3233/NRE-161392.
- Background: PubMed 24051993Sin H, Lee G. Additional virtual reality training using Xbox Kinect in stroke survivors with hemiplegia. Am J Phys Med Rehabil. 2013 Oct;92(10):871-80. doi: 10.1097/PHM.0b013e3182a38e40.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gozde Iyigun, PhD principal investigator
Eastern Mediterranean University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing real boxing training and virtual boxing training in people with Stroke and Hemiparesis, run by Eastern Mediterranean University at 1 site in Cyprus.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Cyprus. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Jan 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wolf Motor Function Test (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03651479, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Nov 2021; AzTrials last refreshed its copy on 7 Nov 2026.